Cleared Special

Nautilus

K220871 · Dornier Medtech America, Inc. · Radiology
Apr 2022
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K220871 is an FDA 510(k) clearance for the Nautilus, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Dornier Medtech America, Inc. (Kennesaw, US). The FDA issued a Cleared decision on April 18, 2022, 24 days after receiving the submission on March 25, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K220871 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2022
Decision Date April 18, 2022
Days to Decision 24 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAA — System, X-ray, Fluoroscopic, Image-intensified
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1650

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